A Drug-Drug Interaction Study of ENV-101 (Taladegib) on Nintedanib Pharmacokinetics in Healthy Subjects

Sponsor

Endeavor Biomedicines, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05817240

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Days)

18.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to learn about the potential effect of ENV-101 (taladegib) on the pharmacokinetics of nintedanib (an approved treatment for idiopathic pulmonary fibrosis) when the two compounds are dosed together in healthy subjects. Participants in this study will receive ENV-101 and/or nintedanib on various days throughout a 10-day period during which they will reside at the clinical trial site.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: taladegib Drug: nintedanib	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A Phase 1, Single-Center, Fixed Sequence, Drug-Drug Interaction Study of ENV-101 (Taladegib) on Nintedanib Pharmacokinetics in Healthy Subjects

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental	Drug: taladegib 100 mg per tablet, dosed once daily Other Names: ENV-101 Drug: nintedanib 100 mg per capsule, dosed once daily

Arm

Intervention/Treatment

Experimental: Experimental

Drug: taladegib

100 mg per tablet, dosed once daily

Other Names:

ENV-101

Drug: nintedanib

100 mg per capsule, dosed once daily

Outcome Measures

Primary Outcome Measures

Nintedanib maximum blood concentration (Cmax) after administration alone and after coadministration with ENV-101 (taladegib) [Day 1 and Day 7]
Time of nintedanib maximum blood concentration (Tmax) after coadministration alone and after coadministration with ENV-101 (taladegib) [Day 1 and Day 7]
Nintedanib absorption to time t (AUC0-t) after administration alone and after coadministration with ENV-101 (taladegib) [Day 1 and Day 7]
AUC represents "area under the concentration-time curve" and measures the amount of drug that is present in the blood from the time of administration to a given time t
Nintedanib total absorption (AUC0-inf) after administration alone and after coadministration with ENV-101 (taladegib) [Day 1 and Day 7]
Nintedanib half-life in the blood (T1/2) after administration alone and after coadministration with ENV-101 (taladegib) [Day 1 and Day 7]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Body Mass Index (BMI) ≥18 and ≤32 kg/m^2
Body weight ≤120kg
Subjects must be willing to be sequestered for 10 consecutive days.

Exclusion Criteria:

Chronic or current use of any prescription medications or acute use within the preceding 30 days or 5 half-lives, whichever is longer, with the exception of contraceptives, prior to study start
Subject has an active infection of hepatitis B or C, or human immunodeficiency virus (HIV) at study start
Subject has a history of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers, within 5 years before study start
Participation in a clinical research trial that included the receipt of an investigational agent or any experimental procedure within 30 days or 5 half-lives, whichever is longer, prior to the screening visit, or planned participation in any such trial at time of study start
Subject has a pulse <45 or >100 bpm; systolic blood pressure >160 mmHg, or diastolic blood pressure >95 mmHg at study start
Subject has pacemaker; is not in sinus rhythm; has a corrected QT interval (QTc; using Fridericia's [QTcF] formula) of >450 ms (for males) and >470 ms (for females) during the Screening Period; or has a left bundle branch block or bifascicular block.
Females and males of reproductive potential who are sexually active and unwilling to use birth control for the duration of the study and for 90 days after their final study dose
Females that are pregnant or lactating
Females and males that are unwilling to refrain from blood or blood product donation for the duration of the study and for 30 days after their final study dose
Males who are unwilling to refrain from sperm donation for the duration of the study and for 90 days after their final study dose
Females who are unwilling to refrain from egg donation for the duration of the study and for 90 days after their final study dose
Subjects with a history of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of ENV-101 (taladegib) or nintedanib
Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study investigative site or the study Sponsor